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Effectiveness and cost-effectiveness of a personalised self-management support intervention for non-hospitalised people living with long COVID

Long COVID PersonalIsed Self-managemenT support EvaluatioN (LISTEN)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36407216
Enrollment
558
Registered
2022-01-27
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID-19 Infections and Infestations

Interventions

Once consented, the participant will be able to access the baseline questionnaires on the LISTEN website. These will ask question about their Long COVID symptoms and how they are coping with them. We

Sponsors

Kingston University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years, AND 2. English or Welsh speaker or have access to someone who can act as a translator 3. Consulted with their GP to rule out serious complications or the need for further investigation in relation to persistent symptoms following COVID-19 infection, AND 4. Experience persistent illness (at least one long COVID symptom for 12 weeks or longer, AND 4.1 Positive SARS-CoV-2 PCR or antigen test (positive COVID19 test) during the acute phase of illness, OR 4.2 Positive SARS-CoV-2 antibody test (positive COVID-19 antibody test) at any time point in the absence of SARS-CoV-2 ( COVID-19) vaccination history, OR 4.3 Loss of sense of smell or taste during the acute phase in the absence of any other identified cause, OR 4.4 Symptoms consistent with SARS-CoV-2 ( COVID-19) infection during the acute phase and high prevalence of COVID-19 at time and location of onset, OR 4.5 At least one symptom consistent with SARS-CoV-2 ( COVID-19) infection during the acute phase AND close contact of a confirmed case of COVID-19 around the time of onset

Exclusion criteria

Exclusion criteria: 1. Any co-morbidities which are progressive or requiring palliative treatment. 2. Have been hospitalised for treatment of COVID-19 symptoms, during the acute phase of COVID illness. 3. Are currently participating in any COVID intervention trial (including contributing to the LISTEN co-design activities).

Design outcomes

Primary

MeasureTime frame
The impact of the LISTEN intervention on routine activities is assessed using the routine activities scale domain of the Oxford Participation and Activities Questionnaire (Ox-PAQ) at baseline and 3 months.

Secondary

MeasureTime frame
1. To evaluate the impact of the LISTEN intervention on emotional well-being as assessed by the relevant domain sub-scale of the Ox-PAQ, at baseline and 3 months. 2. To evaluate the impact of the LISTEN intervention on social engagement as assessed by the relevant domain sub-scale of the Ox-PAQ, at baseline and 3 months. 3. To evaluate the impact of the LISTEN intervention on health-related quality of life as assessed by the Short Form (12) Health Survey, at baseline and 3 months. 4. To evaluate the impact of the LISTEN intervention on fatigue as measured by the Fatigue Impact Scale (FIS) at baseline and 3 months. 5. To assess health-related quality of life expressed as utility using the EQ-5D-5L questionnaire, at baseline, 6 weeks and 3 months. 6. To gather information on healthcare resource use using an adapted client service receipt inventory at baseline, 6 weeks and 3 months. 7. To assess the cost-effectiveness of the LISTEN intervention using an adapted client service receipt inventory at baseline, 6 weeks and 3 months. 8. To explore key anticipated mediators of intervention outcome (namely self-efficacy in the context of COVID-19) using the generalised self-efficacy scale (GSES) with additional context-specific questions at baseline and 3 months 9. To conduct a theory-driven detailed process evaluation within the trial using validated implementation scales to assess intervention acceptability, appropriateness and feasibility (through use of the AIM, IAM and FIM questionnaires, respectively) for a selection of intervention users at 3 months and providers at 3 months and 6 months into recruitment.

Countries

United Kingdom, Wales

Contacts

Public ContactClaire Potter
POTTERC11@CARDIFF.AC.UK+44 29 225 11697

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026